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Association of Contact Lens Adherence With Visual Outcome in the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial.

ABSTRACT: Importance:Although contact lenses have been used for decades to optically correct eyes in children after cataract surgery, there has never been a prospective study looking at contact lens adherence in children with aphakia, to our knowledge. Objective:To evaluate contact lens adherence and its association with visual outcome in a cohort of children treated for unilateral cataract surgery. Design, Setting, and Participants:Secondary analysis of a multicenter randomized clinical trial of 57 infants born from August 22, 2004, to April 25, 2008, who were randomized to 1 of 2 treatments and followed up to age 5 years. Data analysis was performed from August 9, 2016, to December 7, 2017. Interventions:Unilateral cataract extraction and randomization to implantation of an intraocular lens vs contact lens to correct aphakia. Main Outcomes and Measures:Contact lens adherence was assessed by a 48-hour recall telephone interview that was administered every 3 months starting 3 months after surgery to age 5 years. A traveling examiner assessed visual acuity in patients at aged 4.5 years. Adherence to prescribed contact lens use was estimated as the mean percentage of waking hours as reported in 2 or more interviews for each year of life. Results:Of 57 infants who were randomized to contact lens treatment, 32 (56%) were girls, and 49 (86%) were white. A total of 872 telephone interviews were completed. In year 1, a median of 95% participants wore their contacts lenses nearly all waking hours (interquartile range [IQR], 84%-100%); year 2, 93% (IQR, 85%-99%); year 3, 93% (IQR, 85%-99%); year 4, 93% (IQR, 75%-99%); and year 5, 89% (IQR, 71%-97%). There was a tendency for poorer reported adherence at older ages (F = 3.86, P < .001). No differences were identified when the results were analyzed by sex, insurance coverage, or age at cataract surgery. Using linear regression, children who wore the contact lens for a greater proportion of waking hours during the entire study period tended to have better visual acuity at age 4.5 years, even after accounting for adherence to patching (partial correlation = -0.026; P = .08). Conclusions and Relevance:These results confirm that it is possible to achieve a high level of aphakic contact lens adherence over a 5-year period in children. Trial Registration:clinicaltrials.gov Identifier: NCT00212134.

SUBMITTER: Cromelin CH

PROVIDER: S-EPMC5862145 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Patching has been a mainstay in treating unilateral congenital cataract. However, its efficacy has not been rigorously assessed.To examine the association between patching and visual acuity in a cohort of children treated for unilateral congenital cataract.This study was a secondary analysis of a randomized clinical trial (Infant Aphakia Treatment Study) of infants born from August 1, 2004, through December 31, 2008, who were treated with 1 of 2 treatments for unilateral congenital cataract and followed up to 5 years of age. Data analysis was performed from March 1, 2013, to March 1, 2016.Cataract extraction and randomization to receipt of an intraocular lens vs being left aphakic for the first 5 years of life.Caregivers reported patching in the previous 48 hours in quarterly semistructured telephone interviews. The mean number of hours of patching per day was calculated from surgery to the first birthday (n?=?92) and between 12 and 48 months of age (n?=?102). Monocular optotype acuity was assessed at 4½ years of age by a traveling examiner using the Aphakia Treatment Study HOTV protocol.The Infant Aphakia Treatment Study enrolled 114 children; 57 were randomized to each treatment group. At 4½ years of age, optotype visual acuity was assessed in 112 children. The current analyses exclude an additional 3 children (2 who had adverse events that limited visual potential and 1 who had Stickler syndrome), leaving 109 total children analyzed (59 female [54.1%] and 92 white [84.4%]). Caregivers reported patching their children a mean (SD) of 3.73?(1.47) hours per day in the first year of life and 3.43?(2.04) hours per day thereafter. An association between reported patching and treatment was not identified (mean difference in first year, -0.29 hours per day; 95% CI, -0.90 to 0.33 hours per day; mean difference between 12 and 48 months of age, -0.40 hours per day; 95% CI,?-1.20 to 0.40 hours per day). Visual acuity was associated with reported hours of patching in the first year of life (r?=?-0.32; 95% CI,?-0.49 to -0.13) and between 12 and 48 months of age (r?=?-0.36; 95% CI,?-0.52 to -0.18). However, patching accounted for less than 15% of the variance in logMAR acuity at 4½ years of age.These results support the association of occlusion throughout the preschool years with improved visual acuity in infants treated for unilateral congenital cataract. However, similar visual outcomes were achieved with varying amounts of patching. These conclusions should be interpreted in the context of limitations related to generalizability from incomplete data collected in a clinical trial.clinicaltrials.gov Identifier: NCT00212134.

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Association of Contact Lens Adherence With Visual Outcome in the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial.

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